Effects of Acute Hypobaric Hypoxia Exposure on Neurocognitive Performance of Pre-hospital Emergency Service Providers

Institute of Mountain Emergency Medicine

Status: Completed

Conditions: Emergency Medicine; Hypobaric Hypoxia; Cognitive Deterioration; Stress Physiology; Resuscitation

Treatments: Other: Altitude exposure in climate chamber

Study type: Interventional

Funder types: Other

Identifiers

NCT04138446

3489044136

Details and patient eligibility

About

The study aims to evaluate the effects of acute hypobaric hypoxia on cognitive performance (H0: cognitive performance at 200 meters above sea level (asl) = cognitive performance at 3000 meters above sea level = cognitive performance at 5000 meters above sea level).

Before participating in the study, each participant will respond to a questionnaire related to high altitude exposure (prior 3 months), as well as inclusion/exclusion criteria evaluation.

On day 0, after the interview and signed informed consent, the participant will undergo a medical examination that will include a general objective examination. Participants will participate in a training on the emergency and safety procedures of the hypobaric hypoxia facility, as well as a refresh on cardiopulmonary resuscitation procedure.

During the following two days (day 1 and 2) the study protocol will be executed (one test per day). The study protocol envisages:

• a basal cognitive test battery
• blind ascent in the hypobaric chamber to simulated altitude
• cognitive test battery
• 5 minutes of recorded chest compressions on dummies
• cognitive test battery
• blind descent in the hypobaric chamber.

During the stay in the hypobaric hypoxic facility, each participant will be monitored in real time with the Equivital© medical monitoring device.

Before and after the stay in the hypobaric hypoxic facility, a saliva sample will be collected, and psychological tests administered.

Enrollment: 48 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers
• Age 18-60 yr-old
• ASA class I
• Signed informed consent

Exclusion criteria

• Age <18 or >60 yr-old
• ASA class > I
• Informed consent not signed

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 6 patient groups

200-3000

Experimental group

Description:

Day 1: 200m (above sea level) asl Day 2: 3000m asl

Treatment:

Other: Altitude exposure in climate chamber

3000-200

Experimental group

Description:

Day 1: 3000m asl Day 2: 200m asl

Treatment:

Other: Altitude exposure in climate chamber

200-5000

Experimental group

Description:

Day 1: 200m asl Day 2: 5000m asl

Treatment:

Other: Altitude exposure in climate chamber

5000-200

Experimental group

Description:

Day 1: 5000m asl Day 2: 200m asl

Treatment:

Other: Altitude exposure in climate chamber

3000-5000

Experimental group

Description:

Day 1: 3000m asl Day 2: 5000m asl

Treatment:

Other: Altitude exposure in climate chamber

5000-3000

Active Comparator group

Description:

Day 1: 5000m asl Day 2: 3000m asl

Treatment:

Other: Altitude exposure in climate chamber